In this online opinion piece, Mark Davison, head of operations in the EU for rfxcel, outlines everything marketing authorisation holders (MAHs) need to know and what is needed for a seamless serialisation process — before regulators remove the right to trade.

EU FMD

The Falsified Medicines Directive (FMD) imposes strict serialisation requirements on pharmaceutical manufacturers, distributors and dispensers. By February 2019, MAHs will need to start uploading serialisation codes for almost all their prescription medicines to the European Medicines Verification Organisation (EMVO) hub for authentication with pharmacists at the point of sale. Those that can’t will simply be unable to sell their products in Europe.

The FMD is fast approaching, with the denouement arriving 9 February 2019, when the directive is fully enforced and the penalties for non-compliance officially come into play. FMD is an attempt to prevent inauthentic, substandard or harmful medicines entering the supply chain. It imposes strict serialisation, traceability and verification requirements on pharmaceutical manufacturers and their associated wholesalers, distributors and contract manufacturers. In particular, it mandates companies to print a unique identifier (UI) on the packaging of prescription medicines. Furthermore, companies aren’t just responsible for the data that goes on the packaging, they’re responsible for submitting it to the central data hub — EMVO — that will enable pharmacists to authenticate products before they dispense them.

The introduction of serialisation, designed to ensure the authenticity and traceability of individual medicines, promises to improve patient safety and create exciting opportunities for digital health. However, failure to comply with the EU regulation that mandates it means you cannot legally ship your product. No code, no trade. And those in the driving seat are MAHs, who are ultimately accountable for compliance and for uploading UIs to EMVO, which in turn distributes these to the appropriate National Medicine Verification System (NVMO) in the market where the product will be dispensed.

Despite the significance of the regulation, there are some pharmaceutical manufacturers who have yet to put a strategy in place to assure compliance. For these MAHs, it is rapidly becoming imperative to think about strategic decision-making. I developed the following DRASTICprocess.

Decision making

The significance of serialisation is often underestimated. Responsible managers at smaller MAHs will typically have multiple job functions, only one of which is serialisation. Not only that, but it’s typically considered a production issue and operational challenge. Yet serialisation is a board level issue, with ramifications that could directly affect business performance. Indeed, it’s not a manufacturing cost — it’s a business continuity risk that touches every aspect of an organisation.

So, the first step towards serialisation — one that’s often overlooked — is for the MAH to identify and appoint an executive sponsor, ideally with board level oversight, to lead a holistic strategy. Implementation will naturally be delegated to project teams, but executive leadership will be crucial to making things happen quickly.

Reality check

Many organisations don’t understand all their business processes in sufficient detail to overlay serialisation. It’s therefore vital that a multi-disciplinary team (MDT) is convened at the earliest opportunity to map the process flow of the business and establish a roadmap of how serialisation can be applied across multiple organisational boundaries. The MAH should actively engage MDT representatives from manufacturing, supply chain, IT, legal/regulatory and partner/contract management.

Analysis

The barcodes required for FMD must include four lines of data; Global Trade Item Number (GTIN), serial number, batch number and expiry date. Some countries require a fifth element, usually for national reimbursement purposes.

These datasets often live in disparate systems within organisations. The master data — including GTINs — is fixed information that’s commonly stored in an enterprise resource planning (ERP) system. Although that data doesn’t change, it still requires attention to ensure it’s clean and accurate when uploaded to the repositories.

In terms of variable data, the processes required to generate serial numbers, transfer them to production and ensure they’re used appropriately are complex. Analysing where the data sits and how it flows throughout the supply chain lifecycle is key to successfully managing this immensity of numbers; mistakes can lead to expensive delays, medicines shortages and loss of revenue. Serialisation software is therefore an essential requirement to help you maintain control of all aspects of fixed and variable data.

Strategy

The next step is to define your user requirements and establish a template for the solution that will help ensure you’re compliant. You must consider immediate and long-term factors. For example, which markets do you currently ship product to and which do you plan to target in the future? Which products in both your portfolio and your pipeline will need to be coded? Is there a potential future requirement to be able to track and trace products as they journey through the supply chain?

Regulations, from FMD to the US Drug Supply Chain Security Act (DSCSA), serialisation mandates differ from country to country and are constantly evolving. Take the opportunity to become ‘future ready’ by creating a design template that doesn’t just focus on FMD but is flexible enough to be interoperable and implementable between national systems and provides the flexibility to adapt to change as it happens.

Tactics

It’s important to find a vendor that can partner with you to design responsive solutions that go beyond technology. The ability of your vendor to connect to the EMVO is a pre-requisite if you want to be compliant. In addition, a partner should be a recognised provider with experience, credibility and evidence that shows it can implement effectively within tight timeframes.

A good partner will be committed to your success, keeping you abreast of fluctuating global regulations, and collaborating with you to customise solutions that adapt to changes in your business and the wider marketplace.

Implementation

There are numerous factors to consider when selecting and implementing software:

Quality

Serialisation should not be divorced from the founding principle of good manufacturing practice (GMP) — quality. GMP guidelines, as well as data integrity advice from regulators such as the UK MHRA, state that users of computer systems must always be in control. However, multi-tenant serialisation solutions (where multiple independent entities share the same instance of a software solution) can sometimes impose software updates without prior dialogue, leaving users out of control. The potential impact on quality is significant.

Passive acceptance of change is not an option. Multi-tenant solutions require license-holding companies to ensure that risk assessment processes are in place to monitor and adapt to change. By contrast, the most effective solutions allow users to maintain control of their specific software instance and to dictate the timing, relevance and nature of upgrades.

Data validation

An effective solution will focus on both connectivity and data integrity. Some systems concentrate on enabling a connection and flow of data across and between organisations but are blind to data quality. Companies should never assume that the data entering, or generated within, their systems is clean, tidy and accurate. Internal data checks are essential. The best solutions routinely monitor data to detect human error, inaccuracy and duplication. Smart solution providers validate data flowing through a system — in some cases up to 70 data validation checks on incoming records to ensure its integrity — essentially preventing bad data entering the EU hub.

Network connectivity

It’s not enough to ensure your own business is ready: your partners must be ready too. With outsourcing now common across the industry, it’s important that the software you use connects all parties to a single version of the truth. The most effective solution providers connect your entire partner network as standard. This means more than just having a potential connection — it means working with you and your partners to make sure that data really flows.

Communication and continuation

Software selection is not just about technical specifications and functionality. It is also about finding the right cultural fit with a vendor who can support you through your journey to compliance, and provide you with clear and transparent information around issues such as pricing, insight into emerging and future regulations and what that might mean for serialisation strategy and software.

In addition, as the timescales for EMVO on-boarding get steadily tighter, your selected partner should be able and willing to do most of the legwork in connecting you to the hub. Indeed, the right vendor can, with the right circumstances, help you become FMD-compliant within 60 working days.

Conclusion

That said, the fact remains that many companies are still some distance from being fit for purpose. The complexities of serialisation mean that a failure to act now could make it extremely difficult to complete implementation in time for the FMD deadline, or at least to guarantee a seamless end-to-end process.

Moreover, with the fees for registering with EMVO and other affiliate repositories set to increase in June, the internal costs of your project will inevitably rise if you wait. However, the biggest price of non-compliance will be your inability to ship product.

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